Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients
Information source: Tata Memorial Hospital
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pulmonary Fibrosis; Breast Cancer
Intervention: Tamoxifen (Drug); Radiotherapy (Radiation)
Phase: Phase 3
Status: Recruiting
Sponsored by: Tata Memorial Hospital Official(s) and/or principal investigator(s):
Anusheel Munshi, MD, Principal Investigator, Affiliation: Tata Memorial Hospital
Summary
Two hundred and sixty patients with breast cancer will be accrued into the study. After
inclusion in the study, all the patients will be randomized into two arms. Arm 1 will
receive Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be
given followed by tamoxifen sequentially. The patients will be stratified for the following
factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and
b) central lung distance (CLD) > 2 cm.
Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be
evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum
transforming growth factor (TGF) beta levels (baseline and at 6 months) and
diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6
months).
Clinical Details
Official title: A Randomized Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy to Assess the Extent of Pulmonary Fibrosis and Disease Related Control and Survival in Breast Cancer Patients
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Development of Lung fibrosis
Secondary outcome: Locoregional failure and distant failure
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Female.
Criteria:
Inclusion Criteria:
- Patients with large operable lesions (pT/cT > 5 cm) or locally advanced breast
cancers undergoing modified radical mastectomy or breast conservative surgery-(BCS)
who need adjuvant post operative radiotherapy
- Patients post mastectomy requiring radiotherapy because of nodal positivity
- Completed planned chemotherapy schedule
- ER and/or PR positive patients
- Patients decided to be put on tamoxifen
- Patients reliable for follow up
Exclusion Criteria:
- Patients with BCT who have pT1 or pT2 breast lesions (N0,N1)
- Patients for palliative radiotherapy to the chest wall/breast/supraclavicular fossa
- Any patient requiring radiation to the axillary or internal mammary area
- Recurrent disease or metastatic disease
- Patients on concurrent chemotherapy and radiation
Locations and Contacts
Tata Memorial Center, Parel, Mumbai 400012, India; Recruiting
Anusheel Munshi, MD, Phone: -91-22-24177000, Ext: 7144
Additional Information
Starting date: December 2008
Last updated: August 27, 2011
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